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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CS-25802-E
Device Problems Unraveled Material (1664); Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
The customer returned a 2-lumen 8 fr x 20 cm cvc kit catheter with the spring wire guide (swg) still inside of the catheter. The catheter appeared used; however, no defects or anomalies were observed. Visual examination of the swg revealed the guide wire is unraveled from the proximal weld. The distal end of the core wire was undamaged and retained its j shape. The guide wire body also had multiple bends and stretched coils. Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld and that the weld was present at the end of the coil wire. The proximal core wire protruding is rounded and pinched. The distal weld was still intact. Both the proximal and distal welds appeared full and spherical. The broken core wire measured 602mm in length, which met specification; therefore, no pieces appear to be missing. The outside diameter (od) of the guide wire was also found to be within specification. A swg with an od of 0. 846mm from lab inventory passed through the returned catheter from the hub to the tip without restriction. This indicates that a swg with an od of 0. 790mm would be able to pass through the catheter as well. A manual tug test confirmed the distal weld is intact. Other remarks: a device history review was performed and no manufacturing issues were identified. The instructions-for-use (ifu) for this product states that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement the catheter should be withdrawn 2-3cm relative to the spring-wire guide and another attempt should be made to remove it. If resistance is felt again the spring-wire guide and catheter should be removed simultaneously. Applying undue force may cause the spring-wire guide to break. The reported complaint that the guide wire unraveled while using the catheter was confirmed through visual examination of the returned sample. The returned guide wire was kinked, unraveled, and the core wire was broken adjacent to the proximal weld. A lab inventory swg with an od of 0. 846mm advanced through the returned catheter from the hub to the tip without restriction. This indicates that a swg with an od of 0. 790 mm would be able to pass through the catheter as well. No manufacturing defects were found during this investigation. Arrow guide wires of this size (0. 035") are designed and manufactured to withstand a tensile force of 2. 75 pounds force. This internal specification is higher than the bs en iso 11070:2014 standard of 2. 2 pounds force for this size wire. The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking. Guide wire breakage may occur if a force greater than the design specification is applied during removal. Based on these circumstances, it was determined that operational context caused or contributed to this issue.
 
Event Description
The customer alleges resistance was met when inserting the swg (spring wire guide) through the ars (syringe). The swg unraveled after withdrawing with catheter.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The customer alleges resistance was met when inserting the swg (spring wire guide) through the ars (syringe). The swg unraveled after withdrawing with catheter.
 
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Brand NameARROW CVC SET: 2-LUMEN 8 FR X 20 CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7237421
MDR Text Key194264345
Report Number3006425876-2018-00070
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberCS-25802-E
Device Lot Number23F17F0591
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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